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510(k) K981946

CLEARVIEW IM by Unipath , Ltd. — Product Code KTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1998
Date Received
June 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
Review Panel
MI
Submission Type

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Other clearances for product code KTN

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  • K972457 — MONOCOL/LEX-IM TEST (December 1, 1997)
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  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (February 4, 1997)
  • K961550 — QUALITROL MONO CONTROL SERUM SET (September 24, 1996)